Les essais cliniques enregistrés sur Clinicaltrials.gov portant sur le COVID-19 ne déclarent pas une plus grande intention de partager les données personnelles des patients par rapport aux essais non-COVID-19
Year: 2023
Type: dissertation
Abstract: Objectives: To compare intent to share individual participant data (IPD) between COVID-19 and non-COVID-19 trials registered at ClinicalTrials.gov between 01/09/2020 and 01/03/2021. We also evaluated factors independently associated with intent to share IPD and whether intent to share IPD has improved as compared with the pre-pandemic period.Methods: We searched ClinicalTrials.gov for all interventional phase 3 studies registered between 01/09/2020 and 01/03/2021. Then, we identified COVID-19 trials and selected a random sample of non-COVID-19 trials with a ratio 2:1. We compared the intent to share IPD between these trials and with 292 trials registered between 01/12/2019 and 01/03/2020 (pre-pandemic period).Results: We included 148 COVID-19 trials and 296 non-COVID-19 trials. Intent to share IPD did not significantly differ between COVID-19 and non-COVID-19 trials (22.3% versus 27.0%, p = 0.3). Intent to share IPD was independently associated with industry-sponsorship (OR=2.92; 95% CI: 1.65–5.27) and location in the United States (OR=2.93; 95% CI: 1.64–5.41) or the European Union (OR=2.06; 95% CI: 1.03–4.19). The intent to share IPD has not significantly improved compared with the pre-pandemic period (p = 0.16).Conclusion: Data-sharing intent at registration does not seem better for COVID-19 trials
Source: HAL
Author: Ramdjee Kessavdjee, Bruno
Institution: Sorbonne Université
Language: English
Subfield: Information Systems
Field: Computer Science
Domain: Physical Sciences
Open Access status: green
OpenAlex ID: W6983137116